Individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH): Subgroup analyses of efficacy and safety data

Giacomo Novara, Christopher R. Chapple, Francesco Montorsi

Research output: Contribution to journalArticle

Abstract

Objective To evaluate efficacy and safety of silodosin in a pooled analysis of individual patient data from three registrational randomised controlled trials (RCTs) comparing silodosin and placebo in patients with lower urinary tract symptoms (LUTS). Patients and Methods A pooled analysis of 1494 patients from three 12-week, multicentre, double-blind, placebo-controlled phase III RCTs was performed. Efficacy and safety data were assessed across patients with different baseline characteristics. Results Silodosin was significantly more effective than placebo in improving all International Prostate Symptom Score (IPSS)-related parameters, and maximum urinary flow rate (Qmax) regardless of patients age (P <0.041). Comparing the efficacy of silodosin in the different age groups, there were no differences for all the IPSS-related parameters, whereas Qmax improvement was slightly higher in patients aged max (P ≤ 0.02). Silodosin was associated with significantly higher adverse event (AE) rates, compared with placebo, in all patient subgroups, with retrograde ejaculation being the most common. Prevalence of dizziness, orthostatic hypotension, and discontinuation rate was similar with silodosin and placebo in most patient subgroups. Conclusions We analysed the efficacy and safety of silodosin in several patient subgroups, showing that silodosin was more effective than placebo in improving all IPSS-related parameters in all patient subgroups, whereas AEs were similar. Notably, cardiovascular AEs were not higher in patients taking antihypertensive drugs or with mild renal function impairment. Discontinuation rates due to AEs were lower in elderly patients.

Original languageEnglish
Pages (from-to)802-814
Number of pages13
JournalBJU International
Volume115
Issue number5
DOIs
Publication statusPublished - May 1 2015

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Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Safety
Placebos
Therapeutics
Prostate
silodosin
Randomized Controlled Trials
Orthostatic Hypotension
Ejaculation
Dizziness
Antihypertensive Agents

Keywords

  • benign prostatic hyperplasia (BPH)
  • lower urinary tract symptoms (LUTS)
  • silodosin
  • α-blockers

ASJC Scopus subject areas

  • Urology
  • Medicine(all)

Cite this

@article{d96debcd370b4e10bdef420246b2dc42,
title = "Individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH): Subgroup analyses of efficacy and safety data",
abstract = "Objective To evaluate efficacy and safety of silodosin in a pooled analysis of individual patient data from three registrational randomised controlled trials (RCTs) comparing silodosin and placebo in patients with lower urinary tract symptoms (LUTS). Patients and Methods A pooled analysis of 1494 patients from three 12-week, multicentre, double-blind, placebo-controlled phase III RCTs was performed. Efficacy and safety data were assessed across patients with different baseline characteristics. Results Silodosin was significantly more effective than placebo in improving all International Prostate Symptom Score (IPSS)-related parameters, and maximum urinary flow rate (Qmax) regardless of patients age (P <0.041). Comparing the efficacy of silodosin in the different age groups, there were no differences for all the IPSS-related parameters, whereas Qmax improvement was slightly higher in patients aged max (P ≤ 0.02). Silodosin was associated with significantly higher adverse event (AE) rates, compared with placebo, in all patient subgroups, with retrograde ejaculation being the most common. Prevalence of dizziness, orthostatic hypotension, and discontinuation rate was similar with silodosin and placebo in most patient subgroups. Conclusions We analysed the efficacy and safety of silodosin in several patient subgroups, showing that silodosin was more effective than placebo in improving all IPSS-related parameters in all patient subgroups, whereas AEs were similar. Notably, cardiovascular AEs were not higher in patients taking antihypertensive drugs or with mild renal function impairment. Discontinuation rates due to AEs were lower in elderly patients.",
keywords = "benign prostatic hyperplasia (BPH), lower urinary tract symptoms (LUTS), silodosin, α-blockers",
author = "Giacomo Novara and Chapple, {Christopher R.} and Francesco Montorsi",
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T2 - Subgroup analyses of efficacy and safety data

AU - Novara, Giacomo

AU - Chapple, Christopher R.

AU - Montorsi, Francesco

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N2 - Objective To evaluate efficacy and safety of silodosin in a pooled analysis of individual patient data from three registrational randomised controlled trials (RCTs) comparing silodosin and placebo in patients with lower urinary tract symptoms (LUTS). Patients and Methods A pooled analysis of 1494 patients from three 12-week, multicentre, double-blind, placebo-controlled phase III RCTs was performed. Efficacy and safety data were assessed across patients with different baseline characteristics. Results Silodosin was significantly more effective than placebo in improving all International Prostate Symptom Score (IPSS)-related parameters, and maximum urinary flow rate (Qmax) regardless of patients age (P <0.041). Comparing the efficacy of silodosin in the different age groups, there were no differences for all the IPSS-related parameters, whereas Qmax improvement was slightly higher in patients aged max (P ≤ 0.02). Silodosin was associated with significantly higher adverse event (AE) rates, compared with placebo, in all patient subgroups, with retrograde ejaculation being the most common. Prevalence of dizziness, orthostatic hypotension, and discontinuation rate was similar with silodosin and placebo in most patient subgroups. Conclusions We analysed the efficacy and safety of silodosin in several patient subgroups, showing that silodosin was more effective than placebo in improving all IPSS-related parameters in all patient subgroups, whereas AEs were similar. Notably, cardiovascular AEs were not higher in patients taking antihypertensive drugs or with mild renal function impairment. Discontinuation rates due to AEs were lower in elderly patients.

AB - Objective To evaluate efficacy and safety of silodosin in a pooled analysis of individual patient data from three registrational randomised controlled trials (RCTs) comparing silodosin and placebo in patients with lower urinary tract symptoms (LUTS). Patients and Methods A pooled analysis of 1494 patients from three 12-week, multicentre, double-blind, placebo-controlled phase III RCTs was performed. Efficacy and safety data were assessed across patients with different baseline characteristics. Results Silodosin was significantly more effective than placebo in improving all International Prostate Symptom Score (IPSS)-related parameters, and maximum urinary flow rate (Qmax) regardless of patients age (P <0.041). Comparing the efficacy of silodosin in the different age groups, there were no differences for all the IPSS-related parameters, whereas Qmax improvement was slightly higher in patients aged max (P ≤ 0.02). Silodosin was associated with significantly higher adverse event (AE) rates, compared with placebo, in all patient subgroups, with retrograde ejaculation being the most common. Prevalence of dizziness, orthostatic hypotension, and discontinuation rate was similar with silodosin and placebo in most patient subgroups. Conclusions We analysed the efficacy and safety of silodosin in several patient subgroups, showing that silodosin was more effective than placebo in improving all IPSS-related parameters in all patient subgroups, whereas AEs were similar. Notably, cardiovascular AEs were not higher in patients taking antihypertensive drugs or with mild renal function impairment. Discontinuation rates due to AEs were lower in elderly patients.

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